[Federal Register Volume 63, Number 142 (Friday, July 24, 1998)]
[Proposed Rules]
[Pages 39763-39765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19805]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
Medical Use of Byproduct Material; Public Meetings
AGENCY: U.S. Nuclear Regulatory Commission.
ACTION: Notice of public meetings.
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SUMMARY: The Nuclear Regulatory Commission has developed a proposed
rulemaking for a comprehensive revision of its regulations governing
the medical use of byproduct material in 10 CFR Part 35, ``Medical Use
of Byproduct Material,'' and a proposed revision of its 1979 Medical
Use Policy Statement (MPS). Throughout the development of the proposed
rule and MPS, the Commission solicited input from the various interests
that may be affected by these proposed revisions. The Commission now
plans to solicit comments on the proposed rule and MPS through two
mechanisms--publishing the documents in the Federal Register for public
comment (scheduled for August 1998); and convening three facilitated
public meetings, during the public comment period, to discuss the
Commission's proposed resolution of the major issues. The public
meetings will be held in San Francisco, California, on August 19-20,
1998; in Kansas City, Missouri, on September 16-17, 1998; and in
Rockville, Maryland, on October 21-22, 1998. All meetings will be open
to the public. Francis X. Cameron, Special
[[Page 39764]]
Counsel for Public Liaison, in the Commission's Office of the General
Counsel, will be the convener and facilitator for the meetings.
DATES: The first public meeting will be in San Francisco on August 19-
20, 1998, from 8:30 a.m. to 5:00 p.m. each day; the second public
meeting will be in Kansas City on September 16-17, 1998, from 8:30 a.m.
to 5:00 p.m. each day; and the third public meeting will be in
Rockville on October 21-22,1998, from 8:30 a.m. to 5:00 p.m. each day.
ADDRESSES: The San Francisco meeting will be held at the ANA Hotel San
Francisco, 50 Third Street, San Francisco, California 94103, 415-974-
6400. The Kansas City meeting will be held at the Radisson Suite Hotel
Kansas City, Kansas City, 106 West 12th Street, Kansas City, MO 64105,
800-333-3333. The Rockville meeting will be held in the auditorium at
the U.S. Nuclear Regulatory Commission, 11545 Rockville Pike,
Rockville, MD 20852-2738.
FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Special Counsel
for Public Liaison, Office of the General Counsel, Nuclear Regulatory
Commission, Washington D.C. 20555-0001, Telephone: 301-415-1642.
SUPPLEMENTARY INFORMATION:
Background
Following a comprehensive review of its medical use program, the
Commission directed the NRC staff to revise 10 CFR Part 35, associated
guidance documents, and, if necessary, the Commission's 1979 Medical
Policy Statement [Staff Requirements Memorandum (SRM)--COMSECY-96-057,
Materials/Medical Oversight (DSI 7), dated March 20, 1997]. The
Commission's SRM specifically directed the restructuring of Part 35
into a risk-informed, more performance-based regulation. In its SRM
dated June 30, 1997, ``SECY-97-115, Program for Revision of 10 CFR Part
35, `Medical Uses of Byproduct Material' and Associated Federal
Register Notice,'' the Commission approved the NRC staff's proposed
plan for the revision of Part 35 and the Commission's 1979 Medical Use
Policy Statement (MPS). The schedule approved by the Commission in SRM-
SECY-97-115 provides for the rulemaking to be completed by June 1999.
After Commission approval of the NRC staff's program to revise Part
35 and associated guidance documents, the NRC staff initiated the
rulemaking process, as announced in 62 FR 42219 (August 6, 1997).
The proposed rule and MPS were developed using a group approach. A
Working Group and Steering Group, consisting of representatives of NRC,
the Organization of Agreement States, and the Conference of Radiation
Control Program Directors, were established to develop rule text
alternatives, rule language, and associated guidance documents. State
participation in the process was intended to enhance development of
corresponding rules in State regulations, to provide an opportunity for
early State input, and to allow State staff to assess potential impacts
of NRC draft language on the regulation of non-Atomic Energy Act
materials used in medical diagnosis, treatment, or research, in the
States.
The proposed revision of Part 35 is based on the Commission's
directions in the SRMs of March 20, 1997, and June 30, 1997. The
revision is intended to make Part 35 a more risk-informed, performance-
based regulation that will focus the regulations on those medical
procedures that pose the highest risk, from a radiation safety aspect,
with a subsequent decrease in the oversight of low-risk activities;
focus on those requirements that are essential for patient safety;
initiate improvements in NRC's medical program, by implementing
recommendations from internal staff audits, other rulemaking
activities, and results of analyses in medical issues papers;
incorporate regulatory requirements for new treatment modalities; and
reference, as appropriate, available industry guidance and standards.
As part of the rulemaking process, significant issues associated
with the regulation of the medical use of byproduct material and the
revision of the MPS were identified, alternatives were developed for
them, and public input on them was specifically sought. These
alternatives were developed to stimulate input from members of the
public in an effort to encourage all interested parties to contribute
to the development of the revised regulation and were discussed during
facilitated public workshops and meetings throughout the development of
the proposed rule and MPS.
The program for revising Part 35, associated guidance document, and
MPS has provided more opportunity for input from potentially affected
parties (the medical community and the public) than is provided by the
typical notice and comment rulemaking process. Early public input was
solicited by requesting input through Federal Register notices; holding
public meetings of the Working and Steering Groups; meeting with
medical professional societies and boards; putting background
documents, rulemaking alternatives, and a ``strawman'' draft proposed
rule on the Internet and in NRC's Public Document Room; and convening
two facilitated public workshops. Significant regulatory issues were
also discussed at the Part 35 Workshop that was held in conjunction
with the All Agreement States Meeting in October 1997, the Advisory
Committee on the Medical Uses of Isotopes (ACMUI) meetings in September
1997 and March 1998, and the ACMUI subcommittee meetings in February
1998. Input received during these interactions and in writing were
beneficial to the staff in developing the proposed rule and MPS.
Workshops
Based on the substantive public input received during the early
rulemaking process, the Commission believes that it is important for
interests affected by the proposed revisions to have an opportunity to
comment on the proposed rulemaking and MPS, as well as have an
opportunity to discuss the proposed revisions with one another and the
Commission. Accordingly, the Commission is convening three public
meetings, during the public comment period, where representatives of
the interests that may be affected by the proposed rulemaking and MPS
will have an opportunity to discuss the proposed revisions. Although
the meetings are intended to foster a clearer understanding of the
positions and concerns of the affected interests, as well as to
identify areas of agreement or disagreement, it is not the intent of
the meetings to develop a consensus agreement of the participants on
the rulemaking issues.
To have a manageable discussion, the number of participants in each
meeting will be limited. The Commission, through the facilitator for
the meeting, will attempt to ensure participation by the broad spectrum
of interests that may be affected by the proposed rulemaking and MPS.
These interests include: nuclear medicine physicians; physician
specialists, such as cardiologists and radiologists; medical
physicists; medical technologists; nurses; medical education and
certification organizations; radiopharmaceutical interests; hospital
administrators; radiation safety officers; patients' rights advocates;
Agreement States; Federal agencies; and experts in risk analysis. Other
members of the public are welcome to attend, and the public will have
the opportunity to comment on the proposed rulemaking and MPS and to
participate in the meeting discussions at periodic intervals. Questions
about participation
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may be directed to the facilitator, Francis X. Cameron.
The meetings will have a pre-defined scope and agenda focused on
the Commission's resolution of the major issues addressed during the
development of the proposed rule and MPS. However, the meeting format
will be sufficiently flexible to allow for the introduction of
additional related issues that the participants may want to raise. The
meeting commentary will be transcribed and made available to the
participants and the public.
Copies of the proposed revision of Part 35 and the MPS will be
provided to the meeting participants. Also, copies will be available
for members of the public in attendance at the meetings. The
availability of the proposed rule, and associated documents, and the
MPS for individuals who are unable to attend any of the public meetings
will be noted in the Federal Register notices for these documents.
Public comments on the proposed rule and MPS are solicited but, to
be most helpful, should be received by the date that will be announced
in the Federal Register notices on the proposed rule and MPS. Comments
received after this date will be considered if it is practical to do
so, but the Commission only is able to ensure consideration of comments
received on or before this date. Written input and suggestions can be
sent to Secretary, Nuclear Regulatory Commission, Washington, DC 20555-
0001, Attention: Rulemakings and Adjudications Staff. Hand-deliver
comments to 11555 Rockville Pike, Rockville, MD, between 7:30 a.m. and
4:15 p.m. on Federal workdays.
Dated at Rockville, Maryland this 17th day of July, 1998.
For the Nuclear Regulatory Commission.
Frederick C. Combs,
Acting Director, Division of Industrial and Medical Nuclear Safety,
Office of Nuclear Material Safety and Safeguards.
[FR Doc. 98-19805 Filed 7-23-98; 8:45 am]
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